A partner protection package for HIV cure-related trials involving analytical treatment interruptions

Karine Dubé; Tia Morton; Lawrence Fox; Lynda Dee; David Palm; Thomas J Villa; William Freshwater; Jeff Taylor; Gail Graham; William B Carter; John A Sauceda; Michael J Peluso; Annette Rid

doi:10.1016/S1473-3099(23)00267-0

A partner protection package for HIV cure-related trials involving analytical treatment interruptions

Lancet Infect Dis. 2023 Oct;23(10):e418-e430. doi: 10.1016/S1473-3099(23)00267-0. Epub 2023 Jun 6.

Authors

Karine Dubé¹, Tia Morton², Lawrence Fox², Lynda Dee³, David Palm⁴, Thomas J Villa⁵, William Freshwater⁶, Jeff Taylor⁷, Gail Graham⁸, William B Carter⁹, John A Sauceda¹⁰, Michael J Peluso¹¹, Annette Rid¹²

Affiliations

¹ Division of Infectious Diseases and Global Public Health, University of California San Diego School of Medicine, La Jolla, CA, USA; University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA. Electronic address: kdube@health.ucsd.edu.
² Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
³ Delaney AIDS Research Enterprise Community Engagement and Community Advisory Board University of California San Francisco, Department of Medicine, HIV, ID and Global Medicine, San Francisco, CA, USA; AIDS Action Baltimore, Baltimore, MD, USA.
⁴ AIDS Clinical Trials Group Global Community Advisory Board, Chapel Hill, NC, USA; Institute of Global Health and Infectious Diseases Clinical Trials Unit, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁵ HIV Obstruction by Programmed Epigenetics Delaney Collaboratory Community Advisory Board, Gladstone Institutes, San Francisco, CA, USA; National HIV & Aging Advocacy Network, National Minority AIDS Council, Washington, DC, USA; Reversing Immune Dysfunction HIV Delaney Collaboratory Community Advisory Board, Scripps Research, La Jolla, CA, USA; Rockville, MD, USA.
⁶ Philadelphia, PA, USA.
⁷ Delaney AIDS Research Enterprise Community Engagement and Community Advisory Board University of California San Francisco, Department of Medicine, HIV, ID and Global Medicine, San Francisco, CA, USA; Reversing Immune Dysfunction HIV Delaney Collaboratory Community Advisory Board, Scripps Research, La Jolla, CA, USA; Palm Springs, CA, USA; HIV + Aging Research Project, Palm Springs, CA, USA.
⁸ Baltimore, MD, USA.
⁹ Baltimore, MD, USA; BEAT-HIV Collaboratory Delaney Community Advisory Board, Wistar Institute, Philadelphia, PA, USA.
¹⁰ Center for AIDS Prevention Studies, Division of Prevention Sciences, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
¹¹ Department of Medicine, Division of HIV, Infectious Diseases, and Global Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
¹² Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA.

Abstract

Analytical treatment interruptions (ATIs) have become a key methodological approach to evaluate the effects of experimental HIV cure-related research interventions. During ATIs, sex partners of trial participants might be at risk of acquiring HIV. This risk raises both ethical and feasibility concerns about ATI trials. We propose a partner protection package (P3) approach to address these concerns. A P3 approach would provide guidance to investigators, sponsors, and those who are designing and implementing context-specific partner protections in HIV cure-related trials involving ATIs. The approach would also help assure institutional review boards, trial participants, and communities that ATI trials with a P3 would provide appropriate partner protections. We offer a prototype P3 framework that delineates three basic considerations for protecting participants' sex partners during ATI trials: (1) ensuring the scientific and social value of the ATI and the trial, (2) reducing the likelihood of unintended HIV transmission, and (3) ensuring prompt management of any acquired HIV infection. We outline possible ways of implementing these basic considerations.

A partner protection package for HIV cure-related trials involving analytical treatment interruptions

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Grants and funding